Apparatus
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WHAT IS DISSOLUTION?
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Goals of predictive dissolution
test
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FUNCTIONS OF DISSOLUTION
• Optimization of therapeutic effectiveness during
product development and stability assessment
• Routine assessment of production quality to
ensure uniformity between production lots
• Assessment of ‘bioequivalence’, that is to say,
production of the same biological availability
from discrete batches of products from one or
different manufacturers
• Prediction of ‘in-vivo’ availability, i.e.
bioavailability (where applicable)
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TYPES OF APPARATUS
• BASKET APPARATUS
• PADDLE APPARATUS
• RECIPROCATING CYLINDER
• FLOW-THROUGH CELL
• CYLINDER
• SHAFT
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BASKET
a) Vessel :-Made up of
borosilicate glass -Semi
hemispherical bottom
-Capacity 1000ml
Use: Capsules,tablets,delayed
release,
suppositories,floating dosage
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PADDLE APPARATUS
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RECIPROCATING CYLINDER
1.Vessel:Cylindrical
flat bottom glass
vessel
2.Agitation type:
-Reciprocating
-Generally 5-35 rpm
3.Volume of
dissolution fluids :200-
250 ml 4.Water bath:
Maintain at 37±0.5⁰c
Use : Extended
release
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FLOW-THROUGH CELL
• 1.Reservoir:For dissolution
medium
• 2.Pump:-Forces dissolution
medium through cell -holding a
sample -Flow rate 10-100 ml/min
-Laminar flow is maintained
-peristaltic/centrifugal pumps are
not recommended
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PADDLE OVER DISK
• 1.Vessel
• 2.Shaft:
• 3.Stirring elements
• 4.Sample holder : -Disk assembly that hold
the product in such a way that release
surface is parallel with paddle. -Paddle is
directly attached over disk assembly .
-Samples are drawn away b/w the surface of
medium and top of paddle blade.
5.Volume:900ml
• 6.Temperature:32 ⁰c
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SHAFT
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MEDIA FOR DISSOLUTION
• VOLUME
• DEAERATION
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STANDARD VOLUMES
Paddle: 900/1000ml
Basket: 1-4 lit.
Reciprocating cylinder: 200-
250ml
Paddle over Disk: 900ml
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DEAERATION
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EXAMPLES OF TYPICAL MEDIA
• WATER
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FILTERS
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SAMPLING
• AUTOSAMPLING :
BEST FOR SEVERAL TIME POINTS
CAN BE SEMI OR FULLY AUTOMATIC
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TIME POINTS
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Dissolution test for tablets
• tablets or capsules taken orally remain one of the most
effective means of treatment available. The effectiveness of
such dosage forms relies on the drug dissolving in the fluids of
the gastrointestinal tract prior to absorption into the systemic
circulation. The rate of dissolution of the tablet or capsule is
therefore crucial.
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NAME OF THE APPARATU RPM Refer to STANDARD TEMP
DOSAGE S USP VOLUME
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REFERENCE
•USP NF
•IP1996
•Industrial pharmacy BY
Lacchmann Liebermann
•www.dissolutiontech.co
m
•www.usp.org
•www.aapspharmaceutica.
com
•www.authorstream.com
•pharmtech.findpharma.co
m
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QUERIES..??
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Q U E R I E S
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